Description

After discussing with experts and amongst ourselves, we weighed our options in a consultation with the Technology Transfer Office and concluded that the optimal business model is that of a Contract Research Organisation (CRO). That is a company that provides specialized, outsourced research and development services such as drug design, biological testing, clinical trial management, safety monitoring to pharmaceutical, biotech, and medical device industries.

This means that our product would be:

• preclinically verified CAAR receptor structures for MS and other autoimmune diseases that warrant such treatment and/or
• preclinically verified hairpins for targeted miRs and released miRs/siRs for MS and other diseases that warrant such treatment.

This product would be designed and tested on a contract basis for pharmaceutical companies which would then own the particular license and handle the further testing, manufacturing and distribution.

Value Proposition Canvas

The Value Proposition Canvas was used to ensure that our product aligns with the needs of our customers. It helped us map out the customer’s problems and goals, linking them to corresponding features of the product that act as pain relievers or gain creators. This was highly useful for assessing how our product fits in the current market, increasing the likelihood of commercial success ¹.

Value Chain Analysis

A value chain is the series of activities performed to create, deliver, and support a product or service, from initial development to final delivery to the customer. Each step in the process adds value, contributing to the overall product's market competitiveness.

A value chain analysis tailored to our sector–Pharmaceutical biotechnology–helped us understand the structure and flow of industry operations, outlining the role we could perform given our available resources and expertise. Therefore, our business focuses on the research stages up until the preclinical trials. ².

Market Analysis

Outlining and sorting the addressable market for NeuroMuSceteer was of great importance for our business plan. It helped us identify our potential, our opportunities and build an informed expansion strategy. We used a known model, recommended by iGEM Startup SummerSchool, that reveals market size and divides it in subcategories depending on product reach.

TAM (Total Addressable Market): This is the biggest possible market for NeuroMusceteer. It represents all potential worldwide who could use it without accounting for limitations (like location, approval, etc.). Therefore it comprises the total number of MS patients globally ³.

SAM (Serviceable Available Market): This is a smaller slice of TAM. It’s the portion of the total market that we actually reach. Being more familiar with regulations, patient needs and the research community of the EU and US, we can navigate those markets and find partnerships more efficiently ⁴.

SOM (Serviceable Obtainable Market): This is the realistic portion of SAM that your business can capture. Given our patenting approach (national > EU > global) and our relationships with key research centers and clinics in Greece, it is safe to say that the Greek market is the one most within our reach ⁵.

PAM (Potential Available Market): This refers to future growth opportunities. We have established that we intend to extend our design products beyond MS to more autoimmune diseases. This means we could capture the total population of autoimmunity patients, first nationally and eventually internationally ⁶.

Competition

Using competitive intelligence we compared competitor products to ours, starting with direct competitors which we identified as similar research outputs that have progressed to clinical trials.

Databases: WHO International Clinical Trials Registry Platform (ICTRP), clinicaltrials.gov ,EU Clinical Trials Register, pubmed
Key words: Multiple Sclerosis, CAR-T cells,Tregs, Regulatory T cells

VS

Then, we analyzed our approach’s advantages and drawbacks against our indirect competition, the established Disease-Modifying Therapies for MS and other diseases that are currently used by patients. The Venn diagram circles demonstrate our product’s advantages, the competitor’s advantages and industry/patient needs. The winning zone comprises our Unique Selling Point, a demand that only we meet. The losing zone represents the needs that we fail to address and our competition doesn’t. The who cares zone is made up of points that are irrelevant in the comparison and don’t benefit either party, whereas the risky zone is where we are equaled and directly compete.

Intellectual Property Commercialization and Protection

Effectively managing our intellectual property is essential to stay ahead of the fast-paced innovation landscape and sustain our business promotion efforts. Therefore it needs to be prioritized and streamlined.

Out of the available options, our product development is aligned more closely with partnership oriented commercialisation, which would entail:

• establishing a spin-off company to utilize our research results that were produced in the facilities of Aristotle University of Thessaloniki with guidance from its personnel.

• patenting the designs of NeuroMuSceteer either as a unit or separately and licencing them to companies that take on further development.

To ensure that our project is patentable, we conducted a detailed patent search in the Espacenet of the European Patent Office. The results are presented in the table below.

With this investigation, we concluded by process of elimination that there is no patent that is completely indistinguishable or dangerously resembles NeuroMuSceteer.

Intellectual property protection is integral to our business’ viability which is why it should be planned and handled with a lot of consideration. Here is a checklist of important measures we have to take, to ensure the safety of our IP ⁸.

Mission Statement

At NeuroMuSceteer, we are driven by a passion to contribute to the scientific advancement of autoimmune disease treatment. As young scientists, we approach each challenge with curiosity, creativity, and a relentless commitment to improving lives. Our mission is to investigate therapies for multiple sclerosis, bridging the gap between groundbreaking research and real-world patient solutions. Collaboration, ethical responsibility, and a dedication to scientific progress form the core of everything we do. Empowered by our drive to accelerate the development of next-generation therapies, we strive for a future where autoimmune diseases no longer dictate lives, but inspire hope and discovery.

Our Quote: "All for One, One for All".

Our Team

When turning an iGEM team into a company, it is important to evaluate the team composition and dynamic to ensure that it can succeed in the real world and if necessary, add new people. We decided to build our team profile with The Margerison-McCann Team Management Wheel, a framework focused on contribution types ⁹. That way we could identify whether or not our team has the necessary diversity and balance to meet its needs as a business.

Each member, is assigned one of the following roles according to their strengths and preferences in different tasks:

• The Reporter/Adviser gathers and presents information to the team.
• The Creator/Innovator comes up with fresh ideas and new approaches to tasks.
• The Explorer/Promoter identifies new opportunities and seeks them out.
• The Assessor/Developer analyzes these opportunities and works to implement them effectively.
• The Thruster/Organizer makes important decisions, coordinates and drives the team forward to achieve results.
• The Concluder/Producer operates in a systematic and practical way to complete tasks and deliver outputs.
• The Controller/Inspector conducts detailed reviews and quality control.
• The Upholder/Maintainer safeguards standards and values, and supports the team to maintain high performance.

As seen below, our members have diverse experiences, skills and qualities that fulfill all the key roles of a team allowing us to confidently proceed.

We have also built connections with prominent research centers such as the MS center and the Gene and Cell Therapy Center of “G. Papanicolaou” Hospital, whose scientific and financial support is crucial in our first steps. With local government endorsement and a continued relationship with large pharmaceutical companies like Pfizer and Novartis, we are ready to start our entrepreneurial journey.

Growth Strategy and Projections

We assessed our prospects using a BCG Growth/Share Matrix, developed in the 60’s by Boston Counseling Group. In this framework products/services are examined according to their Market Growth (rate at which a market's size or demand is expanding) and Market Share (percentage of total sales or revenue a company or product holds within a specific market), being categorized as one of the following:

Stars: High growth, high market share products that require significant investment but are leaders in their market, with potential to become cash cows.

Cash Cows: Low growth, high market share products that generate more cash than needed for maintenance, making them crucial for funding other areas.

Question Marks: High growth, low market share products that require substantial investment to grow, but their future success is uncertain.

Pets: Low growth, low market share products that often drain resources and are typically rendered obsolete ¹⁰.

In terms of market growth, contract research demand is increasing rapidly due to technological advancements prompting many pharmaceutical companies to outsource their research and development activities to keep up with current research. That next decade will probably see an expansion of the CRO market as is demonstrated by global 2023-2033 forecasts.

What’s more, our ability to adapt our technology and know-how to different diseases grants us access to a wide range of customers. Contract-based partnering with reputable multinational corporations of vast resources also allows our products to reach markets around the world.

This places us in the star category, meaning we need considerable resources and time to move forward but show incredible promise for profitability.

Lean Business Model Canvas

The Lean Business Model Canvas is a simple tool used to outline the main parts of a business idea, focusing on clarity and flexibility. It helped us quickly define our value, target customers, revenue sources, costs, and key activities on one page. The canvas is made for easy updates, allowing us to adjust our ideas and work at peak efficiency in bringing our research to market ¹¹.

Risk Assessment

The risk matrix is a visual tool designed to highlight potential risks that could impact our project. It evaluates them based on two factors: the likelihood of the risk occurring and the severity of its potential consequences. Risks are then classified as very low, low, moderate, high, or critical, depending on both their probability and impact. This simplifies risk prioritization, enabling more effective resource allocation and mitigation strategies.

SWOT Analysis

According to Asana Inc., a SWOT analysis provides useful information that helps businesses identify strengths, weaknesses, opportunities, and threats for a specific project or the overall business plan. It also contributes to strategic planning and evaluation of the competitive position of the project/business ¹².

As a team, we decided to conduct this analysis to ensure that our project has a foundation of scientific rigor while remaining adaptable for future advances in synthetic biology. The SWOT analysis evaluated every aspect of our concept, from the research phase to the potential product distribution. We were also able to identify the advantages of our methodology, the technical and regulatory challenges, opportunities to grow, and threats that could jeopardize the success of the treatment.

Risk Mitigation Resources

It is clear that we are facing several threats, some of which are largely out of our control. Thankfully, there are resources we can rely on to help us navigate those challenges. Mainly, HACRO (Hellenic Association of Contract Research Organizations) ¹³ is a community that welcomes all Greek CROs, promoting continuous training and establishing compliance frameworks, proper communication between stakeholders as well as accurate media representation. Joining HACRO would give us a significant helping hand with processes we are unfamiliar with, thus minimizing critical risks in our business development. To avoid mistakes and decisions that would jeopardize our growth, we would need external consultation services like egg (enter-grow-go) ¹⁴, a programme that supports young Greek entrepreneurs. It provides frameworks and opportunities for business establishment (start-up) and expansion (scale-up).

Due Diligence

This analysis isn’t just a useful tool, it is also necessary for us to be able to secure clients and investors. It is a thorough report of every aspect of our business that is examined by everyone we partner with to verify the integrity of our practices and maintain transparency in the professional relationship.

Below is a sample checklist of all information and documents typically requested by outside parties for partnership, transactions and potential acquisition as provided by the international Law Firm K&L Gates ¹⁵. If the Due Diligence Checklist below does not render, you can view it here.

For CROs specifically, Due Diligence should incorporate detailed accounts confirming sound research practice ¹⁶:

• Research Governance
• Ethics Compliance and Oversight
• Infrastructure and programme management for research
• Procedures and systems – incl IT systems
• Medical Data Management
• Assurance Processes
• Training Policies
• Publication transparency